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Clozaril Related Side Affects....
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A recent paper in a Journal of Clinical Psychiatry supplement reports the FDA has been alerted to more than 140 cases of new-onset diabetes in patients taking clozapine. Three dozen cases involved ketoacidosis, a potentially deadly complication of elevated blood sugar. The paper also cited 19 case reports of diabetes associated with the use of olanzapine, sold as Zyprexa by Indianapolis-based Eli Lilly and Co. In the new research, Dr. Elizabeth Koller, an FDA medical officer, and colleagues culled the agency's MedWatch database for blood sugar trouble associated with clozapine and olanzapine.
New research links Zyprexa (Olanzapine) and Clozaril (Clozapine) with causing serious side effects including: diabetes, hyerglycemia, and pancreatitis. The findings, from researchers at Duke University and the Food and Drug Administration appear as a letter in the Nov. 28 issue of the Journal of the American Medical Association.
They found 11 reports of runaway blood sugar in patients ages 13 to 18 taking clozapine between January 1993 and March last year. They also found nine reports of similar complications among teens taking olanzapine between January 1996 and May 2001. Of the patients on olanzapine, seven had newly diagnosed hyperglycemia. The sugar disorder developed within a week of taking Zyprexa in two patients and within six months for eight others.One patient ultimately died of necrotizing pancreatitis, a condition in which cells in the pancreas die.
One youth taking clozapine also developed pancreatitis more than a month after stopping the drug. That patient survived.
Available information showed that eight of the clozapine patients with high blood sugar never had the problem before. Although the patients on olanzapine also were taking a wide range of other medications, those on clozapine took only one other medication. Researchers estimate the rate of hyperglycemia among young clozapine users is 10 times greater than among the general population.
The very popular MedWatch Database has been accumulating information relating to Clozapine usage and general sugar-quelling medications and the million-dollar question is whether the cases in the MedWatch database are the tip of the iceberg or not. The connection between pancreatitis and these drugs is not fully known, but given its background rate is so rare, it is suspected it's a drug toxicity.
Clozapine's better understood side effect is a potentially grave falloff in white blood cells, a problem called agranulocytosis that the FDA has recognized for some time. Patients starting on clozapine must undergo regular blood tests to watch for the condition.
Last July the drug was linked to dozens of cases of heart complications, including at least 28 deaths since the late 1980s. Novartis, which makes a brand-name version of the pill, has contested those figures. Even so, many mental health experts consider the compound a miracle drug for patients with otherwise untreatable psychosis.
Other Names:
Clozapine
Adverse Effects/
Potential Injuries:
Diabetes
Hyperglycemia
Related Terms:
Zyprexa
Olanzapine
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